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Exact Sciences has submitted to the FDA the second module of its premarket approval application for Cologuard, a DNA test that uses stool samples to screen for colorectal cancer. The Madison, Wis.-based company plans to submit a third and final module using results from its DeeP-C pivotal clinical trial, which it said earlier are likely to be available by March.

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The use of Exact Sciences' Cologuard, a noninvasive stool-based test that screens for colorectal cancer markers, will be covered by Tufts Health Plan. The positive coverage policy for the test started March 15 and is applicable to over 1 million Tufts members in Rhode Island and Massachusetts.

Exact Sciences announced Monday that it is selling 4 million shares in a public offering. It plans to use the money it raises to support marketing efforts for Cologuard, as well as further product development and other business purposes. Cologuard, the firm's stool-based colorectal cancer test, received FDA marketing approval in August.

Exact Sciences said it has earned CLIA certification for its internal laboratory, which comes as the company awaits FDA premarket approval for its Cologuard test designed to diagnose colorectal cancer. The company also said it has contracted with Quintiles to help with the promotion and sales of the test upon its launch.

Exact Sciences has filed for a public offering of its stock, with plans to use the proceeds as working capital and to support its general corporate functions. Last week, the Madison, Wis.-based company finalized its premarket approval application with the FDA for Cologuard, a test used to diagnose colorectal cancer.

Exact Sciences has filed with the FDA the final module of its premarket approval application for Cologuard, an assay for diagnosing colorectal cancer. The module includes data from the company's DeeP-C clinical study, which examined information on about 10,000 patients from 90 clinical sites who were at average risk for colorectal cancer.